Calcaneal Neck Lengthening Osteotomy in Children With Art... | NCT01618812

Studies
Calcaneal Neck Lengthening Osteotomy in Children With Artificial Bone Graft

NCT01618812

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Jun 13, 2012Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Pes Plano Valgus
Flatfeet

Interventions

Lateral lengthening osteotomy of calcaneus

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Oct 2012Estimated

Completion Date

Apr 2013Estimated

First Submitted Date

Jun 11, 2012

First Submission Date that Met QC Criteria

Jun 12, 2012

First Posted Date

Jun 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2012

Last Update Posted Date

Jun 13, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In a group of children with severe and painful flatfeet lengthening procedures of calcaneus can be indicated. In this study the investigators use an artificial bone graft technique to avoid removing bone graft from the iliac crest.

Detailed Description

The aim is to study the clinical and radiological effects of calcaneal lengthening with either autogen bonegraft or a HA-βTCP graft material in a group of children with planovalgus. The hypothesis is that it is possible to achieve a stabile osteotomy with HA-βTCP graft material equal to the use of autogen bonegraft thus avoiding the need to obtaining iliac crest graft material at growing children.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pes plano valgus		Children with painful flatfeet	Procedure: Lateral lengthening osteotomy of calcaneus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lateral lengthening osteotomy of calcaneus	Procedure	Use of artificial bone graft	Pes plano valgus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Healing of osteotomy	Will be followed with repeated clinical examinations until healing	104 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pain
gait disturbance

Exclusion Criteria:

post traumatic conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

• children with planovalgus deformity referred to Dept. of Children's Orthopaedics, Dept of Orthopaedic Surgery E, Aarhus University Hospital from June 2009 until January 2012.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Gottliebsen, PhD-student	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D005413	Flatfoot

Ancestor Terms

ID	Term
D000070558	Talipes
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017886	Durapatite

Ancestor Terms

ID	Term
D006882	Hydroxyapatites
D001031	Apatites
D002130	Calcium Phosphates
D010710	Phosphates

Browse Leaves

Not provided

Browse Branches

Not provided